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Last Updated: November 2, 2024

LABETALOL HYDROCHLORIDE - Generic Drug Details


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What are the generic drug sources for labetalol hydrochloride and what is the scope of patent protection?

Labetalol hydrochloride is the generic ingredient in five branded drugs marketed by Apothecon, Baxter Hlthcare Corp, Caplin, Gland Pharma Ltd, Hikma, Hospira, Rising, Steriscience, Schering, Sebela Ireland Ltd, Andas 5 Holding, Appco, Cadila Pharms Ltd, Endo Operations, Epic Pharma Llc, Eywa, Heritage Pharma, Rubicon, Sandoz, Teva, Unichem, Watson Labs, Zydus Pharms, and Alvogen, and is included in thirty NDAs. Additional information is available in the individual branded drug profile pages.

There are thirteen drug master file entries for labetalol hydrochloride. Thirty-nine suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for LABETALOL HYDROCHLORIDE
US Patents:0
Tradenames:5
Applicants:24
NDAs:30
Drug Master File Entries: 13
Finished Product Suppliers / Packagers: 39
Raw Ingredient (Bulk) Api Vendors: 109
Clinical Trials: 69
Patent Applications: 1,157
What excipients (inactive ingredients) are in LABETALOL HYDROCHLORIDE?LABETALOL HYDROCHLORIDE excipients list
DailyMed Link:LABETALOL HYDROCHLORIDE at DailyMed
Recent Clinical Trials for LABETALOL HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Boston Medical CenterPhase 4
Marshall UniversityPhase 2
Loma Linda UniversityN/A

See all LABETALOL HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for LABETALOL HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up5MG/MLINJECTABLE;INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for LABETALOL HYDROCHLORIDE
Medical Subject Heading (MeSH) Categories for LABETALOL HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for LABETALOL HYDROCHLORIDE

US Patents and Regulatory Information for LABETALOL HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hikma LABETALOL HYDROCHLORIDE labetalol hydrochloride SOLUTION;INTRAVENOUS 213330-005 Mar 18, 2022 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hikma LABETALOL HYDROCHLORIDE IN DEXTROSE labetalol hydrochloride SOLUTION;INTRAVENOUS 213330-001 Nov 9, 2020 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Endo Operations LABETALOL HYDROCHLORIDE labetalol hydrochloride TABLET;ORAL 200908-002 Jul 10, 2012 AB RX No Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Epic Pharma Llc LABETALOL HYDROCHLORIDE labetalol hydrochloride TABLET;ORAL 212990-003 Sep 30, 2020 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Apothecon LABETALOL HYDROCHLORIDE labetalol hydrochloride TABLET;ORAL 075223-001 Nov 20, 1998 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Eywa LABETALOL HYDROCHLORIDE labetalol hydrochloride TABLET;ORAL 207863-003 Feb 4, 2019 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for LABETALOL HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sebela Ireland Ltd TRANDATE labetalol hydrochloride INJECTABLE;INJECTION 019425-001 Dec 31, 1985 ⤷  Sign Up ⤷  Sign Up
Schering NORMODYNE labetalol hydrochloride TABLET;ORAL 018687-004 Aug 1, 1984 ⤷  Sign Up ⤷  Sign Up
Alvogen TRANDATE labetalol hydrochloride TABLET;ORAL 018716-004 Aug 1, 1984 ⤷  Sign Up ⤷  Sign Up
Schering NORMODYNE labetalol hydrochloride INJECTABLE;INJECTION 018686-001 Aug 1, 1984 ⤷  Sign Up ⤷  Sign Up
Alvogen TRANDATE labetalol hydrochloride TABLET;ORAL 018716-003 Aug 1, 1984 ⤷  Sign Up ⤷  Sign Up
Alvogen TRANDATE labetalol hydrochloride TABLET;ORAL 018716-001 May 24, 1985 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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